A nursing student is preparing to give a medication that has a boxed warning. The student asks the nurse what this means. What will the nurse explain about boxed warnings?
They indicate that a drug should not be given except in life-threatening circumstances.
They provide detailed information about medications that can have teratogenic effects.
They alert prescribers to measures to mitigate potential harm from side effects.
They provide information about antidotes in the event that toxicity occurs.
The Correct Answer is C
Choice A Reason:
Boxed warnings, also known as black box warnings, are the strictest warnings put in the labeling of prescription drugs by the FDA when there is reasonable evidence of an association of a serious hazard with the drug. However, they do not necessarily indicate that a drug should only be given in life-threatening circumstances. Instead, they highlight the potential for serious or life-threatening risks and advise on how to use the drug safely.
Choice B Reason:
While some boxed warnings may include information about teratogenic effects (effects that can cause birth defects), this is not their primary purpose. Boxed warnings are broader and can apply to various serious risks, not just teratogenicity. Therefore, this choice is too narrow to be correct.
Choice C Reason:
This is the correct answer. Boxed warnings are designed to alert prescribers to serious or life-threatening risks associated with a drug and provide guidance on how to mitigate these risks. This can include recommendations for monitoring, dosage adjustments, or avoiding certain populations. The goal is to ensure that prescribers are fully aware of the risks and can take appropriate measures to minimize harm to patients.
Choice D Reason:
Boxed warnings do not typically provide information about antidotes for toxicity. While managing toxicity is an important aspect of drug safety, boxed warnings focus on alerting prescribers to serious risks and how to mitigate them, rather than detailing specific antidotes.
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Related Questions
Correct Answer is C
Explanation
Choice A Reason:
Beta2 agonists, such as terbutaline, are commonly used to manage premature labor. These drugs work by stimulating beta2 adrenergic receptors in the smooth muscles of the uterus, leading to relaxation and suppression of contractions. Therefore, questioning the use of a beta2 agonist in this scenario would not be appropriate.
Choice B Reason:
Anticholinergic drugs are not typically used to manage premature labor. They work by blocking the action of acetylcholine in the nervous system, which can lead to various effects such as reduced secretions and relaxation of smooth muscles. However, they are not specifically indicated for stopping uterine contractions, so questioning their use in this context is less relevant.
Choice C Reason:
This is the correct answer. Beta2 antagonists, also known as beta-blockers, work by blocking beta2 adrenergic receptors, which can lead to increased uterine contractions. Using a beta2 antagonist in a patient experiencing premature labor would be counterproductive and could exacerbate the condition. Therefore, it is appropriate to question the use of beta2 antagonists in this scenario.
Choice D Reason:
Alpha1 agonists are not typically used in the management of premature labor. These drugs stimulate alpha1 adrenergic receptors, leading to vasoconstriction and increased blood pressure. They do not have a direct effect on uterine contractions, so questioning their use in this context is less relevant.
Correct Answer is A
Explanation
Choice A Reason:
Clinical trials to assess the teratogenic effects of medications during pregnancy are ethically challenging because they would involve exposing pregnant women and their fetuses to potential risks. The primary concern is the safety of the fetus, as many drugs can cross the placenta and potentially cause harm. Therefore, most of the data on teratogenic effects come from observational studies, case reports, and animal studies rather than controlled clinical trials.
Choice B Reason:
While the FDA has initiatives to improve the safety of medications during pregnancy, it is not accurate to say that a new study will allow testing of medications during pregnancy in the future. The ethical concerns surrounding the exposure of pregnant women to potential teratogens remain a significant barrier. Current efforts focus on improving post-marketing surveillance and encouraging the reporting of adverse effects to gather more data.
Choice C Reason:
Although some women may be reluctant to admit taking medications during pregnancy, this is not the primary reason for the lack of data on teratogenic effects. The main issue is the ethical and practical challenges of conducting clinical trials in pregnant women. Reluctance to report medication use can contribute to underreporting, but it is not the central factor.
Choice D Reason:
Recommending that pregnant women avoid medications is a general precaution, but it does not address the reason why more is not known about teratogenic effects. The avoidance of medications is advised to minimize potential risks, but the lack of data is primarily due to the ethical constraints of conducting clinical trials in this population.
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